Recall Z-1146-2021— Silk Road Medical Inc
Class II · Terminated
Class II FDA medical device recall by Silk Road Medical Inc, initiated 2021-01-13, terminated 2023-01-31. FDA's recall record names no specific 510(k) clearance for this event. Product: ENROUTE Transcarotid Stent System REF SR-XXYY-CS. Reason: Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System..
- Recalling firm
- Silk Road Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-13
- Terminated
- 2023-01-31
- Firm location
- Sunnyvale, CA, United States
Product description
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Reason for recall
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Data sourced from openFDA. This site is unofficial and independent of the FDA.